The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

Device Description

The Stereotaxis Niobe® MNS with Navigant™ NWS is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. It is important to note that the system employs magnetic fields only to orient or steer the tip of a magnetic device.

AI/ML Overview

The Niobe® MNS with Navigant™ NWS is an interventional workstation designed for the intravascular navigation of magnetic devices. The referenced document (K060967) does not contain a typical "acceptance criteria" table with specific quantitative benchmarks for performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found for diagnostic or screening devices.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices for expanded indications. The "performance data" section describes a clinical study that was used to support this claim, rather than detailing specific acceptance criteria the new device had to meet.

Here's an analysis based on the provided text, focusing on how the device "meets acceptance criteria" through substantial equivalence and the study cited:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a conventional table of acceptance criteria with quantified performance metrics for the Niobe® MNS with Navigant™ NWS itself in this document. The "acceptance criteria" for this 510(k) submission appear to be centered around demonstrating that the device is substantially equivalent to predicate devices for its expanded indications, particularly given the new neurovasculature indication.

The primary "performance" that is reported in support of this is the safety and efficacy of magnetically guided devices when used in the neurovasculature, as demonstrated by a predicate device's clinical study.

Acceptance Criterion (Implicit)	Reported Device Performance (via predicate device study)
Substantial Equivalence for Expanded Indications: The Niobe® MNS with Navigant™ NWS (with expanded indications) must be substantially equivalent to predicate devices for navigating compatible magnetic devices through tissue to designated target sites, particularly in the neurovasculature, without pre-shaping the tip prior to vessel insertion.	A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature. Stereotaxis states this clinical study is applicable to support substantial equivalence of the Niobe® MNS with Navigant™ NWS due to the predicate device successfully demonstrating clinical safety and efficacy of utilizing magnetic navigation with magnetic guidewires in the neurovasculature.
Technological Characteristics Equivalence:
- Mechanical function and hardware remain the same as the existing Niobe® MNS with/Navigant™ NWS.	"The mechanical function and hardware of the existing Niobe® MNS with/Navigant™ NWS, will remain as is today." (Implicitly met by design).
- Intended use (to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping).	"They are intended to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion." (Stated as characteristic shared with predicate Telstar® MNS).
- Same intended use (navigating magnet-tipped devices in various vasculatures including heart, coronary, neuro, and peripheral).	"They have the same intended use, to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction." (Stated as characteristic shared with predicate Telstar® MNS).
- Same operating field strength (0.15 Tesla).	"They have the same operating field strength, 0.15 Tesla." (Stated as characteristic shared with predicate Telstar® MNS).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."

Sample Size: The document does not specify the sample size used in this clinical study.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states it was a "Clinical Study."

3. Number of Experts and Qualifications

The document makes no mention of experts used to establish ground truth for a test set, nor their qualifications. The study described is a clinical study on a predicate device demonstrating safety and efficacy in actual procedure, not an evaluation of diagnostic accuracy requiring expert interpretation of outputs.

4. Adjudication Method

The document does not describe any adjudication method. This is consistent with the nature of the study, which evaluated the safety and efficacy of a medical procedure/device rather than the interpretation of data/images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device in question (Niobe® MNS with Navigant™ NWS) is a steerable catheter control system for navigation, not a diagnostic imaging system that would typically involve human readers interpreting results with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The concept of "standalone performance" (algorithm only performance without human-in-the-loop) is not applicable or discussed in this context. The Niobe® MNS with Navigant™ NWS is an interventional workstation that requires a human operator (interventional cardiologist/radiologist) to direct the navigation based on real-time imaging and clinical judgment. It does not operate as a standalone "algorithm" in the way a diagnostic AI might.

7. Type of Ground Truth Used

The "ground truth" for the clinical study referenced would have been clinical outcomes data related to the safety and efficacy of the procedure. This would include (but isn't explicitly detailed):

Successful navigation to target sites.
Absence of adverse events or complications.
Achievement of the therapeutic goal for which the navigation was used.

This is inferred from the description "demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of an AI/algorithm development. The "performance data" section refers to a clinical study of a predicate device, which would be an evaluation or validation study for that device, not a training set for an AI.

9. How Ground Truth for Training Set Was Established

As no training set (in the AI sense) is mentioned, there is no information on how its ground truth would have been established. The clinical study for the predicate device used real-world patient outcomes as its "truth" for evaluation.

Summary

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Ko60967

Premarket Notification Frentarkst Notifications of Navigant™ NWS October 17, 2006 Page 1 2

Appendix 1: 510(k) Summary per 21CFR §807.92

Submitter'sinformation	Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Dennis Pozzo, Regulatory Affairs SpecialistPhone: 314-678-6136March 22, 2006	OCT 1 9 2006
Device/classificationname	• Device Name:Niobe® MNS w/Navigant™ NWS• Classification/Common name:Steerable Catheter Control System & Stereotaxic Instrument• The marketed device(s) to which substantial equivalence is claimed:- Stereotaxis Guidewire and Stereotaxis Telstar® Magnetic NavigationSystem [MNS]- Navigant™ Navigation Workstation [2.1] [NWS2]- Stereotaxis Niobe® Magnetic Navigation System
Devicedescription	The Stereotaxis Niobe® MNS with Navigant™ NWS is an interventionalworkstation for the intravascular navigation of appropriately equipped,magnetically adapted, devices (e.g., catheters or guidewires) through tissue todesignated target sites. The system uses computer-controlled permanentmagnets for orienting the tip of a magnetic device. It is important to note thatthe system employs magnetic fields only to orient or steer the tip of amagnetic device.
Intended use	The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and leftheart, coronary vasculature, neurovasculature and peripheral vasculature byorienting the device tip in a desired direction.

Continued on next page

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60967

Premarket Notification Stereotaxis, Niobe® MNS w/Navigant™ NWS

October 17, 2006
Page 2

Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

Technological characteristics The Niobe® MNS with/Navigant™ NWS with expanded indications is substantially equivalent to the predicate Niobe® MNS with/Navigant™ NWS in that:

1. The mechanical function and hardware of the existing Niobe® MNS with/Navigant™ NWS, will remain as is today.
1. They are intended to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion.

The Niobe® MNS with/Navigant™ NWS with expanded indications is substantially equivalent to the predicate Telstar® MNS in that:

They are intended to navigate compatible magnetic devices through tissue 1. to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion.
1. They have the same intended use, to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.
1. They have the same operating field strength, 0.15 Tesla.

Performance data

A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature. Stereotaxis is of the position that this clinical is applicable to support substantial equivalence of the Niobe® MNS with Navigant™ NWS. The rationale for this position is based upon the success of the Telstar® MNS demonstrating clinical safety and efficacy of utilizing magnetic navigation with magnetic guidewires in the neurovasculature.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stereotaxis. Inc. % Mr. Dennis Pozzo Regulatory Affairs Specialist 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108

Re: K060967

Trade/Device Name: Stereotaxis® Niobe® Magnetic Navigation System (MNS) with Navigant™ Navigation Workstation (NWS) Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable catheter control system Regulatory Class: II Product Code: NDO Dated: September 28, 2006 Received: September 29, 2006

Dear Mr. Pozzo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, IDA way publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

OCT 1 9 2006

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Page 2 -- Mr. Dennis Pozzo

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-100. This letter will allow you to begin marketing your device as described in your Section 50(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mor ohtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely vours.

fu-P.dth

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix 2: Indications for Use Statement

Statement

The indications for Use Statement:

510(k) Number: Ko660967

Device Name: Stereotaxis ® Niobe® Magnetic Navigation System (MNS) with Navigant™ Navigation Workstation (NWS)

The Niobe® MNS with Navigant™ NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Page

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C Division of General, Restorative, ____________________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number_

The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.

Regulation Number and Section

§ 870.1290 Steerable catheter control system.

(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).